EDC

TrialKit EDC is a cloud-native Electronic Data Capture system designed for modern clinical trials of all types — traditional, hybrid, decentralized, and fully remote. As the first full-featured EDC platform available as a native mobile app for iOS, Android, and Mac, TrialKit enables research teams to collect, manage, and store clinical data from any location, at any time. It is built to accommodate mid-study protocol amendments without downtime, making it a flexible and cost-effective alternative to rigid legacy EDC systems.

TrialKit serves a broad range of clinical research stakeholders, from CROs managing multiple sponsor trials to pharmaceutical and biotech companies, academic investigators, and study coordinators overseeing global studies. Its flexible licensing and scalable architecture make it equally suited to small pilot studies and large multinational Phase III and IV trials.

Who Benefits from TrialKit EDC

• Clinical Research Organizations (CROs): Simplify study builds, manage multiple trials simultaneously, and maintain high data quality across sponsors.
• Pharmaceutical and Biotech Companies: Gain faster insights, improve regulatory compliance, and accelerate time to market.
• Investigators and Academic Researchers: Access an affordable, self-configurable system with powerful tools suited to limited budgets.
• Sponsors and Study Coordinators: Monitor trial progress in real time, reduce site burden, and drive operational efficiencies across global studies.

Core EDC Features and Capabilities

• Mid-study changes with zero downtime: TrialKit's configurable architecture supports protocol amendments — including adding cohorts and sites or modifying dosing regimens — with a single click and no time-consuming migrations.
• Multiple studies, single sign-on: Sponsors and sites gain controlled access to all studies via web or mobile app through one unified sign-on.
• Easy eCRF design: A universal drag-and-drop design tool allows users to move field variables freely on forms, create edit checks and annotated PDFs, and export form data dictionaries.
• Reusable forms and study builds: Save weeks on study setup by repurposing forms, variables, and conditional actions. Any study can be replicated and repurposed across multiple accounts from anywhere.
• Secure site management: Over 250 configurable permissions and form access rights allow administrators to grant sites and users precisely the level of access they require.
• Integrated query management: Perform queries via web or mobile app, or use system-generated queries from real-time data updates. Complete audit trails are available to monitor study risk.

How TrialKit EDC Improves Clinical Trials

• Increases trial efficiency: Real-time, remote data entry and monitoring via mobile devices accelerates data collection, reduces the need for site visits, and streamlines overall trial workflows.
• Reduces errors and improves data accuracy: Built-in data validation checks flag discrepancies at the point of entry. Direct Data Capture (DDC) tools further minimize transcription errors throughout the study lifecycle.
• Enhances compliance: Audit trails, role-based access controls, and adherence to FDA 21 CFR Part 11, HIPAA, and GDPR help ensure all data handling meets regulatory requirements.
• Supports decentralized and hybrid trials: Data can be collected remotely via mobile devices, wearable technology, or home visits, supporting patient engagement and real-time data access.
• Scalable for any study size: Cloud-based access, multilingual support, and flexible data structures allow seamless expansion from small pilots to large global trials.

Integrated TrialKit Platform Modules

• eSource and Direct Data Capture (DDC): Collect source data directly at the point of care, online or offline, eliminating duplicate entry and reducing errors.
• eCOA and ePRO: Enable patients to report outcomes from anywhere via a mobile-friendly design supporting both in-clinic and remote participation.
• eConsent: Secure, remote-ready consent workflows simplify participant onboarding and maintain compliance from any location.
• eTMF: A cloud-based, compliant document management system with real-time access, version control, and audit trails to maintain inspection readiness.
• Randomization and Trial Supply Management (RTSM): Configurable web and mobile module for randomizing and tracking subjects, drug supply, devices, and inventory throughout a study.
• Payment Manager: Automates site payment calculations, streamlines approvals, and reduces administrative burden without reliance on spreadsheets or third-party tools.
• Clinical Adjudication: Supports blinded adjudication processes including event tracking, committee workflows, and secure documentation.
• Medical Coding (TrialKit Coder): Integrated support for WHODrug and MedDRA coding to standardize medical terms and improve data consistency.
• API Integrations (Open eClinical Platform): A proprietary machine-learning API transforms unstructured EHR and other data into usable structured data to improve accuracy at the source.
• Televisits (TrialKit Engage): Built-in video conferencing enables remote patient assessments, improving accessibility and retention without switching platforms.
• PACS Imaging (TrialKit PACS): Upload, store, and view DICOM images directly within TrialKit, eliminating the need for a separate imaging platform.
• AI Analytics (TrialKit AI): Built-in artificial intelligence surfaces trends and risks in real time, enabling teams to respond proactively before issues escalate.

TrialKit EDC is a fully cloud-based, mobile-first platform compliant with FDA 21 CFR Part 11, HIPAA, and GDPR. Its end-to-end integration with companion modules — spanning eConsent, eCOA, eTMF, RTSM, medical coding, imaging, and AI analytics — makes it a comprehensive clinical trial management solution suitable for organizations of all sizes seeking speed, flexibility, and regulatory confidence.